FDA计划制订数据完整性指南啦----关注2015自然年FDA指南计划

julia朱玉姣

FDA publishes List of Guidances planned for 2015

FDA公布其2015年计划指南清单

At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. The list is subdivided into different categories. It contains for example also guidances planned in connection with the topics Clinical Pharmacology or Clinical/Statistical.

每年初，FDA都会照例公布其在该年度的计划指南清单。2015年也是一样。该文件有5页，清单分为不同类别，包括了诸如与临床药理或临床/统计学有关的主题相关指南。

CGMP is a category of its own for which "only" three new guidances are planned for 2015:

CGMP是2015年计划中一个独立的类别，是仅有的3个新指南。

• A questions & answers (Q&A) paper on the topic data integrity  
• 数据完整性问答
• CGMP rules for outsourced facilities (pharmacy compounding)  
• 外包场所（药房）CGMP原则
• Rules for the repackaging of certain drug products by pharmacies and outsourcing facilities
• 药房和外包场所的特定药品重新包装规定
  

Especially the Q&A document could be interesting.

特别是问答文件可能会引起大家兴趣。

The guidances planned for the category "Pharmaceutical Quality/CMC" are also closely related to GMP. The following guidances are examples of the 13 guidances planned altogether in this category:

指南计划的类别“药品质量/CMC”同样与GMP紧密相关。以下是此类指南中一起计划的13个指南举例：

• A guidance on the development of NIR procedures  
• NIR程序研发指南
• A guidance on microbiological quality considerations in non-sterile drug product manufacturing
• 非无菌药品生产中微生物质量考量指南
• A guidance on quality metrics and risk-based inspections.
• 质量指标和基于风险的检查指南
  

Concerning biotechnology specifically there are two separate categories with the topics biopharmaceutics and biosimilarity.

关于生物技术专题，有2个单独的类别是关于生物药学和生物类似物的。

Conclusion: The number of new guidances in the GMP environment planned for 2015 is relatively limited but some of the topics (such as data integrity and quality metrics) could be very interesting. Furthermore, it remains to be seen if all of the planned guidances will really be published in 2015.

结论：2015年GMP环境下的新指南数量相对有限，但有些论题（例如数据完整性和质量指标）可能会让大家很感兴趣。另外，还要看是否所有这些计划的指南都真的能在2015年公布。

Please also see the "New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015".

请参见“2015自然年计划公布的新的和修订的CDER指南草案”。

Postscript: If you are interested in the topic quality metrics: In the framework of the 6th European GMP-Conference the ECA offers a Pre-Conference on this topic taking place in Heidelberg on 8 June 2015.

又及：如果你对质量指标感兴趣，ECA有一个关于此议题的讨论将于2015年6月8日在海德堡第6届欧洲GMP会议上举行。

一沙一叶

很期待FDA怎么说

jackycheung

谢谢朱老师带来的及时消息，支持支持

大呆子

想学习一下问答

道路漫长黑暗

三个新指南都挺需要，等发布

Mint

密切关注中

zhuliu2007

谢谢版主，随时关注

天上没有月亮

数据完整性，据说部分国内企业，外贸专门一套仪器设备，内销一套。外贸的上服务器联网审计追踪，内销的还是老样子。。。。

liwenxian

谢谢分享，学习了